IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer Dental implant systems are de

FDA device recall Z-0778-2016 · posted 2016-02-09 · Terminated

Recall details

Recalling firm

Zimmer Dental Inc

Reason for recall

Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.

Action taken

Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form. It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records. For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.

Root cause

Labeling Change Control

Status

Terminated

Product code

DZE

Quantity affected

1059

Distribution

Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico

Date initiated

2016-01-06

Date posted

2016-02-09

Date terminated

2016-05-06

Location

Carlsbad, CA

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